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Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

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ClinicalTrials.gov Identifier: NCT01655784
Recruitment Status : Recruiting
First Posted : August 2, 2012
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
JD Mocco, Vanderbilt University Medical Center

Brief Summary:

This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter).

Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.


Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Procedure: Coil Embolization with larger Diameter Coils Procedure: Coil Embolization with Standard Diameter Coils Not Applicable

Detailed Description:

Primary Study Objective: Occlusion rate: angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization.

Secondary Objectives:

  1. Treatment related morbidity and mortality, as measured by the NIH stroke scale.
  2. Packing density as measured by volumetric filling of the aneurysm.
  3. Clinical outcome at 3-6 and 12-18 months post-coiling, as measured by the modified Rankin scale.
  4. Re-hemorrhage and re-treatment rates.

Study Design: FEAT will be a prospective, randomized trial comparing the utilization of 0.014-0.0155" coils versus smaller diameter coils in mid-sized aneurysm treatment. The 0.014-0.0155" bare platinum coils (Stryker, Natick, MA) are FDA-approved and in common use at institutions in this country and across the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to either the framing coil treatment or the non-framing coil treatment. Data on each patient will be collected at the time of enrollment and treatment, and at first and second follow-up visits.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
Study Start Date : August 2012
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Active Comparator: Eighteen Coils (0.014-0.0155 inch)
Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.
Procedure: Coil Embolization with larger Diameter Coils
Eighteen Coils placed in cerebral aneurysm
Other Names:
  • Eighteen Coils
  • Cerebral Aneurysm Embolization
  • Aneurysm Coils

Active Comparator: Standard Coils (0.014 inch)
Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.
Procedure: Coil Embolization with Standard Diameter Coils
Cerebral aneurysms will be embolized with standard diameter coils.
Other Names:
  • Eighteen Coils
  • Cerebral Aneurysm Embolization
  • Aneurysm Coils




Primary Outcome Measures :
  1. Occlusion Rate [ Time Frame: 12-18 Month Follow-up ]
    Occlusion rate: Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization.


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete) ]
    Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.

  2. Packing Density [ Time Frame: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed) ]
    Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.

  3. Clinical Outcome [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.

  4. Re-hemorrhage and Re-treatment Rates [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Re-hemorrhage rates will be tracked and recorded during both follow-up time points.

  5. Mortality [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ]
    Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.

  6. Retreatment [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Retreatment rates will be tracked and recorded during both follow-up time points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon).
  2. The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.015-0.0155" platinum coil.
  3. Patients are 18-80 years of age (inclusive).
  4. Patient must be Hunt and Hess grade 0 to 3.
  5. Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
  6. Aneurysm 6-14 mm in maximum diameter.
  7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular treatment.
  8. The patient has not been previously randomized into this trial or another related ongoing trial.
  9. The aneurysm has not been previously treated by coiling or clipping.

Exclusion Criteria:

  1. Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the FEAT inclusion criteria (ie - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses).
  2. Target aneurysm has had previous coil treatment or has been surgically clipped.
  3. Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.
  4. Inability to obtain informed consent.
  5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655784


Contacts
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Contact: Stephanie A Smith, M.A. 6159360815 Stephanie.Anne.Smith@vumc.org

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Locations
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United States, California
UCSF-Fresno, Community Regional Medical Center Recruiting
Fresno, California, United States, 93701
Contact: Rebekah Garcia    559-499-6636    rgarcia@fresno.ucsf.edu   
Principal Investigator: Amir Khan, MD         
United States, Colorado
Radiology Imaging Associates Recruiting
Englewood, Colorado, United States, 80112
Contact: Lisa Kodis    720-493-3403    lisa.kodis@riaco.com   
Principal Investigator: Donald Frei, MD         
Colorado Neurological Institute Completed
Englewood, Colorado, United States, 80113
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Jessica Smith    352-273-7773    jessica.smith@neurosurgery.ufl.edu   
Principal Investigator: Adam Polifka, MD         
Lyerly Neurosurgery - Baptist Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Ebreo    904-398-0125    nancy.ebreo@bmcjax.com   
Principal Investigator: Eric Sauvageau, MD         
University of South Florida - Tampa General Recruiting
Tampa, Florida, United States, 33606
Contact: Marlene Martin    813-844-4639    marlenecmartin@tgh.org   
Principal Investigator: Maxim Mokin, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Mary Faulkner    859-323-0616    mary.faulkner@uky.edu   
Principal Investigator: Justin Fraser, MD         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
North Worcester, Massachusetts, United States, 01655
Contact: Mary Howk    774-441-8442    mary.howk@umassmed.edu   
Contact: Kimberly Ty       kimberly.ty@umassmed.edu   
Principal Investigator: David Rex, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ron Ball    734-647-5436    rmball@med.umich.edu   
Contact: Karen Frisch    734-232-4843    kfrisch@med.umich.edu   
Principal Investigator: Aditya Pandey, MD         
Sub-Investigator: Greg Thompson, MD         
United States, Mississippi
University of Mississippi Recruiting
Jackson, Mississippi, United States, 39216
Contact: David Gordy    601-815-3605    dgordy@umc.edu   
Principal Investigator: Gustavo Luzardo, MD         
United States, New York
University of Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Hartney    716-218-1000 ext 5105    mhartney@ubns.com   
Principal Investigator: Adnan H Siddiqui, MD, Ph.D.         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Jonah Stein    212-241-6008    jonah.stein@mountsinai.org   
Principal Investigator: Johanna Fifi, MD         
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Dawn Madigan    631-444-8121    dawn.madigan@sbumed.org   
Principal Investigator: David Fiorella, MD, PhD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Wendy Jenkins    336-716-3842    wejenkin@wakehealth.edu   
Principal Investigator: Stacey Q Wolfe, MD         
United States, Ohio
Mayfield Clinic Completed
Cincinnati, Ohio, United States, 45219
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Williams    614-685-8622    jennifer.williams@osumc.edu   
Principal Investigator: Ciaran Powers, MD, PhD         
United States, South Carolina
Medical Center of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Meredith Robinson    843-792-7971    robme@musc.edu   
Principal Investigator: Raymond Turner, MD, FAANS         
Sub-Investigator: Aquilla Turk, DO         
United States, Tennessee
Tennessee Interventional Associates - Erlanger Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Amy Knox    423-778-6216    amy@tiiarad.com   
Contact: Katie Bryant    423-778-6216    katie@tiiarad.com   
Principal Investigator: Harris Hawk, MD         
Fort Sanders Regional Medical Center Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Charita Braker    865-541-2925    charitabraker@tnvi.org   
Principal Investigator: Keith Woodward, MD         
University of Tennessee Medical Center - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Kevin Sellers    865-305-5651    kasellers@mc.utmck.edu   
Contact: Jennifer Henry    865-300-1563    jehenry@mc.utmck.edu   
Principal Investigator: Andrew Ferrell, MD         
University of Tennessee - Memphis - Methodist Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amanda Nolte    901-259-5316    annolte@semmes-murphey.com   
Principal Investigator: Adam Arthur, MD, MPH         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Michael Froehler, MD, PhD    615-936-0815    m.froehler@vanderbilt.edu   
Contact: Stephanie A Smith, MA, CCRP    615-936-0815    stephanie.anne.smith@vanderbilt.edu   
Principal Investigator: Michael Froehler, MD, PhD         
United States, Texas
University of Texas - Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Kim Dutton-Johnson    214-648-7815    kim.dutton@utsouthwestern.edu   
Principal Investigator: Babu Welch, MD         
Sub-Investigator: G. Lee Pride, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Charlotte Gilman, RN    804-828-9882    cgilman@mcvh-vcu.edu   
Principal Investigator: John Reavey-Cantwell, MD, MS         
United States, West Virginia
West Virginia University Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jennifer Domico, RN, CCRP    304-598-6930    domicoj@wvuhealthcare.com   
Principal Investigator: Ansaar Rai, MD         
Sub-Investigator: Jeffrey Carpenter, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Stryker Neurovascular
Investigators
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Principal Investigator: J D Mocco, MD, MS Icahn School of Medicine at Mount Sinai

Additional Information:
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Responsible Party: JD Mocco, Adjunct Assoc Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01655784     History of Changes
Other Study ID Numbers: 120439
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

Keywords provided by JD Mocco, Vanderbilt University Medical Center:
aneurysm
intracranial aneurysm
cerebral aneurysm
intracranial embolization
aneurysm embolization
intracranial coil
eighteen coils
bare platinum coils
GDC Coil
Target Coil

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases